Head of Regulatory Affairs Europe & International

Job content

ROLE OVERVIEW

We are currently searching for a Head of Regulatory Affairs for Europe and International who will work closely and partner with internal departments and department management to manage efficiently and effectively assigned regulatory requirements. You will combine your knowledge of scientific, regulatory, and business issues to ensure that products are developed, manufactured, and distributed to meet regulatory requirements. In alignment with Regulatory Affairs management, you function independently as a decision-maker on regulatory issues, assures on both a strategic and tactical level that submission/registration/renewal deadlines are met, and supports new product development. You effectively communicate and negotiates You effectively communicate, interact, and negotiate with regulatory authorities during the development and review process to ensure submission approvals. Lastly, you will properly interpret and apply regulatory requirements and is recognized as a discipline expert and resource in European/International Regulatory Affairs.

WHAT YOU CAN EXPECT TO DO IN THE ROLE:

Reporting to the EVP, Regulatory & Scientific Affairs, you will partner with the Head of Regulatory Countries and Head of Commercial EU & International to ensure that regulatory licenses are submitted to grow the business. You liaise, negotiate, and orchestrate meetings and teleconferences with global Health Authorities; strategize and plan for Health Authority meetings; and capture all communications via contact reports. You direct the team for preparation of information necessary for submissions (including initial INDs, IND amendments) in accordance with the regulations and relevant guidelines (domestic and international). You will lead the team to manage updates to CMC, nonclinical, and clinical information included in regulatory submissions (e.g., IB, protocols, safety reports). You direct the process for preparation and maintaining annual licenses, registrations/listings. You liaise with CROs and external vendors which support publishing and medical writing activities. You will Mentor/Lead/train and provide guidance to direct reports.

FOR THIS ROLE YOU WILL NEED:

• Bachelor’s degree in Life/Health Sciences required; Master’s Degree, Pharm D, or PhD preferred
• Minimum of 15 years of experience in pharmaceutical / biotech regulatory affairs with strong negotiation and operational execution skills.
• A strategic thinker with the ability to work both independently with minimal direction and within project teams, etc. to attain company goals.
• Excellent verbal and written communication skills in English.
• Proven experience in leading new MAA submissions and health authority interactions
• Strong knowledge of current EU and international regulatory guidelines.
• Excellent leadership skills, proven ability to lead high performing teams.
• Ability to work well in a deadline-driven environment.
• Self-Starter is required.

COMPANY INFORMATION:

Founded in 2011, Covis Pharma is a private equity backed global specialty pharmaceutical company that markets therapeutic solutions in 50+ countries, for patients with life-threatening conditions and chronic illnesses. Our paramount concern is patient’s outcomes as we focus on improving the health of people with serious medical conditions. Apollo Global Management is the private equity sponsor of Covis Pharma.

If you are looking to be a part of a global, vibrant, and fast-growing organization, have a positive attitude, seeking career development and acceleration and are energized by being a part of improving the lives of the patient’s we serve, we are the perfect match for you.

OUR OFFER TO YOU:

By joining Covis Pharma you will be a part of a dynamic and energized team with a vested interest in your personal and professional development. You will be able to provide input into impactful decisions and be a part of shaping our company’s future. The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us. We offer opportunities for advancement and support this through multiple development channels.

Our inclusive company culture brings unique perspectives and embraces diversity of thought. We actively seek to hire and develop the best and brightest team members from all backgrounds ensuring our continued success into the future.

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

GET TO KNOW US:

Find out more about Covis Pharma by visiting www.covispharma.com

Find out more about Apollo Global Management by visiting www.apollo.com